Class I Medical Device Recall: GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System

Product: GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System

Description

Part #

GEM 4000 BG/Hct/Lytes/CO-Ox - iQM

00027407508, 00027415008, 00027430008,

00027445008, 00027360008

GEM 4000 BG/Hct/Lytes/G/L/CO-Ox - iQM

00027407510, 00027415010, 00027430010,

00027445010, 00027360010

GEM 4000 BG/Hct/Lytes/CO-Ox/tBili - iQM

00027407509, 00027415009, 00027430009,

00027445009, 00027360009

GEM 4000 BG/Hct/Lytes/G/L/CO-Ox/tBili - iQM

00027407511, 00027415011, 00027430011,

00027445011, 00027360011

These products were manufactured and distributed from May, 2006 through July 2011.

Use: The GEM Premier 4000 PAK cartridges are used on the GEM Premier 4000 portable critical care system by health care professionals to rapidly analyze whole blood samples at the point of health care delivery in a clinical setting and in a central laboratory.

Recalling Firm:

Instrumentation Laboratory Company

180 Hartwell Road

Bedford, Massachusetts 01730-2443

Reason for Recall: Potassium test results on the GEM Premier 4000 are too low when compared to a reference analyzer; with biases exceeding the allowable error claim of plus or minus 0.5 mmol/L by as much as 2.0 mmol/L. Use of this product may lead to inappropriate patient treatment and may cause serious adverse health consequences, including death.

Public Contact: Customers may contact the company at 1- 800-678-0710 and press 2 at the prompt.

FDA District: New England

FDA Comments

On July 14, 2011, the company issued a revised "Urgent Field Safety Notification" letter to GEM Premier 4000 customers. The letter described the product, problem, updated issue description and actions to be taken. The customers were directed to follow the instructions to disable the potassium test to eliminate the potential of erroneous result reporting. The company also requested their customers to complete and return the Mandatory Response Tracking Form immediately by FAX at 1-781-861-4207 or by email to ra-usa@ilwww.com

The letter also noted an important change to customer actions from June's Urgent Field Safety Notification. Previously, the company mailed U.S. and Canadian customers an Urgent Field Safety Notification between June 2 - 3, 2011. The letter included a response (tracking) form.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.